Emergency Contraception

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					Emergency Contraception
   and Adolescents
            Emergency Contraception


                                      Objectives

 By the end of this presentation,
  participants will be able to:
   Discuss need for EC among
    adolescents
   Describe clinical components of EC
   Understand the challenges and
    opportunities for increasing EC use
    at the patient, provider, and health
    systems level
                                             PRCH 2009
          Emergency Contraception

                 What Is Emergency
                Contraception (EC)?

 A safe and effective way of
  preventing pregnancy in cases of:
   Contraceptive failure
   No contraceptive use
   Unplanned or forced intercourse
 Reasonably effective prevention
  method for up to 120 hours after
  unprotected intercourse
                                    PRCH 2009
          Emergency Contraception



          Adolescents Need EC

 The U.S. has one of the highest
  teen pregnancy rate in the
  industrialized world.

 82% of teen pregnancies are
  unplanned

                                    PRCH 2009
Emergency Contraception

         Teen Pregnancy Rates
              Worldwide, 2000




                          Per 1000




                                     PRCH 2009
            Emergency Contraception

                         Unprotected Sex
                                Happens
 21% of females whose first sex was
  between 1999-2002 used no method
  of contraception

 13% of adolescents experience a
  contraceptive method failure during
  their first year of use


                                        PRCH 2009
       Emergency Contraception
        Female Contraceptive Use at 1st
             Intercourse by Year of 1st
                           Intercourse
2002 National Survey of Family Growth




                                        PRCH 2009
                        Emergency Contraception

                   HS Students Contraceptive Use
                              at Last Intercourse
                              YRBS 2007




*This data only reflects oral contraceptives and not rates of injectable
contraceptives use                                                         PRCH 2009
            Emergency Contraception


           Sexual Assault and EC

 >50% of all rapes occur in young
  women under 18 years old
 For teens, 5.3% of rapes lead to a
  pregnancy.
 Emergency contraception should be
  offered to all survivors of sexual
  assault.

                                       PRCH 2009
Emergency Contraception



           Indications for EC




                          PRCH 2009
         Emergency Contraception


                              Human Error


 Inconsistent contraceptive use

 Incorrect contraceptive use

 Unplanned intercourse


                                      PRCH 2009
          Emergency Contraception


          Method Failure: Patch
 Patch off for 24 hours or
  more during patch-on
  weeks

 More than two days late
  changing a patch

 Late putting patch back on
  after patch-free week
                                    PRCH 2009
         Emergency Contraception


           Method Failure: Ring

 Taken out for more than three
  hours during ring-in weeks

 Same ring left in more than
  five weeks in a row

 Late putting ring back after ring-
  out week
                                   PRCH 2009
                Emergency Contraception


               Method Failure: Others


   Condom breaks or slips
   2 or more missed active OCPs
   DMPA shot 14 or more weeks ago
   Expelled IUD
   3 > = hours late taking a POP
   Diaphragm or cervical cap dislodges


                                          PRCH 2009
Emergency Contraception


                 Methods of EC




                           PRCH 2009
                Emergency Contraception

                         Brand Name
                  Levonorgestrel ECPs

 Dedicated Product: Plan B One-Step
   FDA approved July 2009
   ingle tablet formulation 1.5mg of levonorgestrel

 Original Plan B
   Two tabs of 750 mcg levonorgestrel
   Approved in 1999
   Approved for OTC 18 and older in 2006

 Both are now OTC for 17 and older
                                                 PRCH 2009
             Emergency Contraception

                             Generic
                   Levonorgestrel EC

 Next ChoiceTM, a generic dedicated
  product approved June 2009
   Two tabs of 750 mcg levonorgestrel
   For prescription use by women 16 and
    younger
   OTC for women 17 and older


                                                17
                                         PRCH 2009
          Emergency Contraception

      Summary: FDA Approved
       Dedicated EC Products
 Plan B OneStep
   Single dose


 NextChoice
   Generic


 Original PlanB
   Now discontinued
                                           18
                                    PRCH 2009
           Emergency Contraception

                   Combined Oral
           Contraceptives as ECPs


 Yuzpe method
  Combined oral contraceptive
   pills (OCPs) containing combined
   ethinyl estradiol and either
   norgestrel or levonorgestrel


                                     PRCH 2009
              Emergency Contraception

          The Copper-T Intrauterine
                            Device

 Insert within 5 days
 Highly effective: Reduces risk of
  pregnancy by more than 99%
 Rarely used for EC alone
 Cannot use levonorgestrel IUD
  (Mirena) for EC

                                        PRCH 2009
 Emergency Contraception

Clinical Components of
                   EC



  Regimens
  Efficacy




                           PRCH 2009
           Emergency Contraception

                    Levonorgestrel-Only
                              Regimen
 Each packet includes
   A single course of treatment

 Both tablets may be taken at the
  same time (to increase
  compliance) with
   No reduction in effectiveness
   No increase in side effects
                                     PRCH 2009
              Emergency Contraception


                                  ECP Efficacy
 Exact efficacy rates are difficult to
  determine
   Minimum efficacy for levonorgestrel
    regimen is 49%
 Can substantially reduce the change of
  pregnancy after an episode of
  unprotected sex
   Most effective the sooner taken

                                           PRCH 2009
              Emergency Contraception

                         How Long After the
                            Morning After?
     2002 WHO Trial of Levonorgestrel-Only EC
          Regimen Taken in Single Dose


                      p=.16




Von Hertzen H, et al. Lancet 2002;360:1803-1810   PRCH 2009
               Emergency Contraception

                    Mechanism of Action of
                    Levonorgestrel-Only EC

 Disrupts normal follicular development
  and maturation
   Results in ovulation or delayed ovulation
    with deficient luteal function
 May also interfere w/sperm migration
  and function at all levels of the genital
  tract


                                            PRCH 2009
           Emergency Contraception

                         Does EC
            Prevent Implantation?

 2 studies: No effect on the
  endometrium
 1 study: Taken before LH surge,
  altered luteal phase secretory
  pattern of glycodelin in serum
  and the endometrium

                                     PRCH 2009
            Emergency Contraception

            Does Levonorgestrel-Only
            EC Prevent Implantation?


 Studies in animals: Levonorgestrel
  administered in doses that inhibit
  ovulation has no post-fertilization
  effect



                                      PRCH 2009
           Emergency Contraception

                   Mechanism of Action:
                       Combined ECPs

 Can inhibit or delay ovulation
 Older studies have shown
  histologic or biochemical
  alterations in the endometrium.
 More recent studies have found
  no such effects on the
  endometrium.
                                     PRCH 2009
                   Emergency Contraception

                    Mechanism of Action:
                        Combined ECPs
 Additional possible mechanisms:
   Dysfunctional ovulation
   Interference w/corpus luteum
    function
   Thickening of the cervical mucus *
   Alterations in tubal transport of
    sperm, egg, or embryo*
   Direct inhibition of fertilization*
    *No clinical data exist regarding these mechanisms
                                                         PRCH 2009
  Emergency Contraception

Side Effects & Complications:
      Levonorgestrel v. Yuzpe




                   Significant at p<0.01
                                           PRCH 2009
             Emergency Contraception


                                       EC is Safe
 No deaths or serious complications
  have been causally linked to EC
 No serious reactions have been
  reported
 WHO Medical Eligibility Criteria
   No situations in which risk of using
    Levonorgestrel-only or Yuzpe
    regimen EC outweigh benefits
                                              PRCH 2009
              Emergency Contraception


               Few Contraindications
 Known or suspected pregnancy
   Only because it is INEFFECTIVE, not
    because it is harmful
   Will NOT increase the risk of miscarriage
 Hypersensitivity to any component of
  the product
 Undiagnosed abnormal genital bleeding

                                          PRCH 2009
 Emergency Contraception

 Adolescent Access to EC:
Challenges & Opportunities




                           PRCH 2009
               Emergency Contraception

                             Challenges and
                              Opportunities
 To utilize EC, young women (under 18)
  must
   Be aware of the option
   Locate a provider
   Obtain a prescription
   Find the money to pay for the pills
   Fill prescription at a pharmacy that has
    EC
   Take pills at correct time

                                               PRCH 2009
           Emergency Contraception

                         Challenges and
                          Opportunities
 Patient Level

 Provider Level

 Health Systems and Public Policy
  Level



                                     PRCH 2009
Emergency Contraception



  Patient Level




                          PRCH 2009
             Emergency Contraception

                  Few Young Women Are
                           Aware of EC

 28% of teen girls have heard of EC
 40% of teens who know about EC
  understand that the pills should be
  taken after, not before, sex




                                       PRCH 2009
            Emergency Contraception

             Patient Misconceptions
           Create Barriers to EC Use


 Beliefs that EC functions as an
  abortifacient
 Fear that the drug would harm fetus
 Confusion over fertility cycle and
  timing


                                      PRCH 2009
        Emergency Contraception


                         Other Barriers
 Perceived lack of confidentiality
 Lack of money and/or insurance
 Lack of transportation
 Inability to locate a healthcare
  provider w/in the limited and
  effective timeframe
 Belief that pelvic examination is
  mandatory
 OTC exclusion of minors
                                    PRCH 2009
Emergency Contraception



   Provider Level




                          PRCH 2009
           Emergency Contraception

              Many Providers Do Not
        Discuss EC w/ Young Patients


 Of pediatricians with adolescent
  patients:
   20% report prescribing EC
   24% report counseling
    adolescents about EC


                                     PRCH 2009
             Emergency Contraception

                    Providers Need More
                      Training About EC

 2001 survey of pediatricians found:
   72.9% were unable to identify any of
    the FDA-approved methods of EC
   Only 27.9% correctly identified the
    timing for initiation
   31.6% felt comfortable prescribing
    EC

                                         PRCH 2009
             Emergency Contraception

            Provider Misconceptions
                 Can Discourage Use
 2001 survey of pediatricians found:
   22% believed that providing EC
    encourages adolescent risk-taking
    behavior
   52.4% would restrict the number of times
    they would dispense EC to a patient
   12% cited moral or religious reasons for
    not prescribing
   17% were concerned about teratogenic
    effects

                                         PRCH 2009
             Emergency Contraception

                 Providers Can Remove
                 Clinical Barriers to EC
 No pelvic examination or pregnancy
  test required by ACOG or FDA
 Pregnancy test prior to EC treatment
  is recommended only if:
   Other episodes of unprotected sex
    occurred that cycle
   LMP (last menstrual period) was not
    normal in duration, timing, or flow


                                          PRCH 2009
            Emergency Contraception

                             Providers Can
                          to Facilitate Use
 Discuss EC with ALL patients
 Assess patient’s previous knowledge of
  EC
 Discuss patient’s definition of
  “unprotected sex” - when should patient
  fill/call in for prescription for EC
 Frame scenarios according to patient’s
  current contraceptive plan, how it might
  fail, and how and when to use EC

                                        PRCH 2009
           Emergency Contraception

              Providers Can Facilitate
                                    Use
 Providers must take into account
  patient’s:
   Knowledge of reproductive
    physiology
   Ability to understand the regimen
   Moral perceptions of contraception
   Misconceptions about the drug’s
    mechanism of action
   Barriers that may restrict access
                                     PRCH 2009
              Emergency Contraception

                 Providers Can Facilitate
                                     Use

 Instruct patient on use:
   More effective the sooner it is taken
   Taking two pills at once increases
    compliance and no increase in side
   effects
   Call provider if there is no menstrual
    period w/in three weeks after taking
    EC

                                        PRCH 2009
          Emergency Contraception


          Counseling Key Points

 Taking EC once during the cycle
  does not protect women from
  pregnancy for the entire cycle
 Having unprotected sex after EC use
  can increase pregnancy risk
 To be effective, EC must be used
  each and every time a woman has
  unprotected sexual intercourse.

                                    PRCH 2009
             Emergency Contraception

                     Facilitating Use in
                                Practice

 Write: advanced prescription w/
  multiple refills (12 recommended)
 Discuss: condoms and assess for
  STI risk
 Explain: EC is not an abortifacient,
  nor is it teratogenic


                                         PRCH 2009
         Emergency Contraception

                 Facilitating Use in
                            Practice
 Train office staff on EC
   Importance of timely
    appointments
   Lack of required exam for
    prescriptions
   OTC for patients over 17
                                   PRCH 2009
              Emergency Contraception

                      Facilitating Use in
                                 Practice

 List yourself as an EC provider on
  www.not-2-late.com
 Compile list of pharmacists in area that
  dispense EC
 Refer patients to
   www.not-2-late.com


                                        PRCH 2009
            Emergency Contraception

          Opportunities for Bridging
            Contraceptive Services

 Cost of EC may prohibit multiple
  use w/in a cycle (~$25-$50)
 During visit, discuss alternative
  and ongoing methods of
  contraception that are more
  effective and less expensive

                                      PRCH 2009
         Emergency Contraception

             Counseling Teens About
                Contraception Method
 Have you tried anything to prevent
  pregnancy in past?
 Any problems with a previous
  method?
   Trouble remembering to take the
    pill?
   Concerns over privacy with the
    pill/patch?
   Difficulty using condoms
    consistently?
   Cost barriers?                 PRCH 2009
              Emergency Contraception

                             Initiating
             Contraception: Quickstart

 Consider QuickStart initiation of an
  ongoing birth control method on day of
  EC administration
 Patient should bleed in ~ 2 weeks
 If administering DMPA:
    Patient should return in 2 weeks for
     pregnancy test

                                        PRCH 2009
               Emergency Contraception

             Provider Opportunities for
                       Facilitating Use

 Display posters and materials about EC
 Work w/ teen patients to establish a
  “plan” in the event of contraceptive
  failure, including identifying:
   A pharmacy that will fill prescription
   A method of transportation to pharmacy
   A means of locating or borrowing funds
    for pills

                                         PRCH 2009
          Emergency Contraception

           Provider Level: Ethical
                      Obligations
 If provider does not feel
  comfortable or competent
  counseling patient or writing
  prescription for EC:
    S/he must make a referral to
     someone who can
    Refer patient to www.not-2-
     late.com
                                    PRCH 2009
Emergency Contraception

    Health Systems and
     Public Policy Level




                          PRCH 2009
         Emergency Contraception

              Path to OTC Access:
                      August 2006

 FDA announced that Plan B will be
available OTC to women 18 and older

     Minors still need to obtain a
prescription (in states w/out pharmacy
                access)

No medical or public health reason for
 limiting adolescents’ access to EC

                                             58
                                      PRCH 2009
             Emergency Contraception


                   2009 Court Decisions


        US District Court rules: FDA must
        make Plan B available to women
        17 and older within 30 days and
        reconsider the scientific evidence
March   supporting any age limit on
2009    access to EC


        Women 16 and younger still need
        a prescription to access EC
                                                 59
                                          PRCH 2009
             Emergency Contraception

               Generic Dedicated EC
                  Product Approved
         Generic dedicated EC product,
June     NextChoice TM approved by the
2009     FDA to be available by
         prescription only

August   NextChoiceTM approved for OTC
 2009    sales to women 17 and older



                                                60
                                         PRCH 2009
            Emergency Contraception

          Single-Dose Dedicated EC
                  Product Approved

       FDA approves Plan B OneStep
       with a dual label

       Women 16 and younger still need
July
       a prescription to access EC
2009
       OneStep begins to replace
       original Plan B in pharmacies as
       manufacturing ends.
                                                 61
                                          PRCH 2009
               Emergency Contraception


                   What’s Next for EC?

 Generics are free to enter the market
   Until Aug 2012, Plan B has market
    exclusivity on single dose products
 Per the March 2009 rulings, the FDA is
  still under obligation to reconsider age
  restrictions on all EC products
 Data still supports increased access
  for minors
                                                 62
                                          PRCH 2009
            Emergency Contraception

             Advanced Provision &
        Pharmacy Access to Minors
 Does NOT increase risk taking
  behavior
   Does not decrease condom use
   Does not decrease contraceptive use
   Does not increase number of sexual
    partners Increase risk for STIs

 DOES increase use of EC
   Risks are reduced from episodes of
    unprotected sex and/or contraceptive
    failure that occur
                                          PRCH 2009
                  Emergency Contraception

                    Advanced Provision: No
                  Increase in Risk Behavior
                                        Advance Rx: ~2xs as
                 Receive EC in            much EC use as
                   advance              control (15% vs. 8%)
                                             No decrease in
 2004 study of                                 condom or
 young women                                contraceptive use
randomized to:
                                             No increase in
                    Receive                 unprotected sex
                 instructions on        Advance Rx: used EC
                 how to get EC           sooner than control
                                         group (10 vs. 21 hrs
                                                          PRCH 2009
             Emergency Contraception

           Pharmacy Access Does Not
               Increase Risk Behavior
 A 2005 study of 2117 young women
 Improved access group no more likely
  to:
    Miss a pill
    Switch birth control methods
    Forgo using a condom
 Frequency of intercourse, amount of
  unprotected sex, & number of sexual
  partners similar among the study groups

                                       PRCH 2009
             Emergency Contraception

            Addressing Concerns About
                             STI Risk

 While EC does NOT protect against
  STIs or HIV:
   2005 study: Young women obtaining
    EC from pharmacist were no more
    likely to get an STI
   Product’s label clearly states that
    regimen does not protect against
    STIs or HIV

                                       PRCH 2009
               Emergency Contraception


                                     Conclusions

 EC: safe and effective method of preventing
  pregnancy
 Can prevent pregnancies when taken within
  indicated window
 Should be readily available to all women,
  especially adolescents
 Advanced provision and pharmacy access
  will not increase health risks for young
  women

                                             PRCH 2009
Emergency Contraception

    Please Complete Your
         Evaluations Now




                          PRCH 2009
                         Emergency Contraception


                                   Provider Resources
   Resources:
   www.prch.org - Physicians for Reproductive Choice and Health
   www.aap.org - The American Academy of Pediatrics
   www.acog.org - The American College of Obstetricians and
    Gynecologists
   www.adolescenthealth.org - The Society for Adolescent Medicine
   http://www.aclu.org/reproductiverights/ - The Reproductive
    Freedom Project of the American Civil Liberties Union
   www.advocatesforyouth.org – Advocates for Youth
   www.guttmacher.org – Guttmacher Institute
   www.cahl.org/ - Center for Adolescent Health and the Law
   www.gynob.emory.edu - The Jane Fonda Center of Emory University
   www.siecus.org - The Sexuality Information and Education Council of
    the United States
   www.arhp.org - The Association of Reproductive Health
    Professionals
   www.rhtp.org – Reproductive Health Technologies Project


                                                                   PRCH 2009
              Emergency Contraception

                 Provider Resources:
            Emergency Contraception
 PRCH’s Emergency Contraception: A Practitioner’s
  Guide
 ARHP Reproductive Health Model Curriculum
 For information and a directory of EC providers,
  women can visit www.not-2-late.com
 Managing Contraception:
  http://www.managingcontraception.com
 Back Up Your Birth Control: Building Emergency
  Contraception Awareness Among Adolescents, A
  Tool Kit, Academy for Educational Development,
  http://www.aed.org/Publications/upload/ECtoolkit32
  83.pdf
 Plan B Website:
  http://go2planb.com/ForConsumers/Index.aspx
 National Sexual Assault Hotline 1-800-656-HOPE.
  Provides victims of sexual assault with free,
  confidential, around-the-clock services.       PRCH 2009

				
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